scholarly journals Accuracy and agreement of national spine register data for 474 patients compared to corresponding electronic patient records

Author(s):  
Ole Kristian Alhaug ◽  
Simran Kaur ◽  
Filip Dolatowski ◽  
Milada Cvancarova Småstuen ◽  
Tore K. Solberg ◽  
...  

Abstract Purpose Data quality is essential for all types of research, including health registers. However, data quality is rarely reported. We aimed to assess the accuracy of data in a national spine register (NORspine) and its agreement with corresponding data in electronic patient records (EPR). Methods We compared data in NORspine registry against data in (EPR) for 474 patients operated for spinal stenosis in 2015 and 2016 at four public hospitals, using EPR as the gold standard. We assessed accuracy using the proportion correctly classified (PCC) and sensitivity. Agreement was quantified using Kappa statistics or interaclass correlation coefficient (ICC). Results The mean age (SD) was 66 (11) years, and 54% were females. Compared to EPR, surgeon-reported perioperative complications displayed weak agreement (kappa (95% CI) = 0.51 (0.33–0.69)), PCC of 96%, and a sensitivity (95% CI) of 40% (23–58%). ASA classification had a moderate agreement (kappa (95%CI) = 0.73 (0.66–0.80)). Comorbidities were underreported in NORspine. Perioperative details had strong to excellent agreements (kappa (95% CI) ranging from 0.76 ( 0.68–0.84) to 0.98 (0.95–1.00)), PCCs between 93% and 99% and sensitivities (95% CI) between 92% (0.84–1.00%) and 99% (0.98–1.00%). Patient-reported variables (height, weight, smoking) had excellent agreements (kappa (95% CI) between 0.93 (0.89–0.97) and 0.99 (0.98–0.99)). Conclusion Compared to electronic patient records, NORspine displayed weak agreement for perioperative complications, moderate agreement for ASA classification, strong agreement for perioperative details, and excellent agreement for height, weight, and smoking. NORspine underreported perioperative complications and comorbidities when compared to EPRs. Patient-recorded data were more accurate and should be preferred when available.

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Sophie Relph ◽  
◽  
Maria Elstad ◽  
Bolaji Coker ◽  
Matias C. Vieira ◽  
...  

Abstract Background The use of electronic patient records for assessing outcomes in clinical trials is a methodological strategy intended to drive faster and more cost-efficient acquisition of results. The aim of this manuscript was to outline the data collection and management considerations of a maternity and perinatal clinical trial using data from electronic patient records, exemplifying the DESiGN Trial as a case study. Methods The DESiGN Trial is a cluster randomised control trial assessing the effect of a complex intervention versus standard care for identifying small for gestational age foetuses. Data on maternal/perinatal characteristics and outcomes including infants admitted to neonatal care, parameters from foetal ultrasound and details of hospital activity for health-economic evaluation were collected at two time points from four types of electronic patient records held in 22 different electronic record systems at the 13 research clusters. Data were pseudonymised on site using a bespoke Microsoft Excel macro and securely transferred to the central data store. Data quality checks were undertaken. Rules for data harmonisation of the raw data were developed and a data dictionary produced, along with rules and assumptions for data linkage of the datasets. The dictionary included descriptions of the rationale and assumptions for data harmonisation and quality checks. Results Data were collected on 182,052 babies from 178,350 pregnancies in 165,397 unique women. Data availability and completeness varied across research sites; each of eight variables which were key to calculation of the primary outcome were completely missing in median 3 (range 1–4) clusters at the time of the first data download. This improved by the second data download following clarification of instructions to the research sites (each of the eight key variables were completely missing in median 1 (range 0–1) cluster at the second time point). Common data management challenges were harmonising a single variable from multiple sources and categorising free-text data, solutions were developed for this trial. Conclusions Conduct of clinical trials which use electronic patient records for the assessment of outcomes can be time and cost-effective but still requires appropriate time and resources to maximise data quality. A difficulty for pregnancy and perinatal research in the UK is the wide variety of different systems used to collect patient data across maternity units. In this manuscript, we describe how we managed this and provide a detailed data dictionary covering the harmonisation of variable names and values that will be helpful for other researchers working with these data. Trial registration Primary registry and trial identifying number: ISRCTN 67698474. Registered on 02/11/16.


1999 ◽  
Vol 38 (04/05) ◽  
pp. 287-288 ◽  
Author(s):  
J. van der Lei ◽  
P. W. Moorman ◽  
M. A. Musen

1999 ◽  
Vol 38 (04/05) ◽  
pp. 339-344 ◽  
Author(s):  
J. van der Lei ◽  
B. M. Th. Mosseveld ◽  
M. A. M. van Wijk ◽  
P. D. van der Linden ◽  
M. C. J. M. Sturkenboom ◽  
...  

AbstractResearchers claim that data in electronic patient records can be used for a variety of purposes including individual patient care, management, and resource planning for scientific research. Our objective in the project Integrated Primary Care Information (IPCI) was to assess whether the electronic patient records of Dutch general practitioners contain sufficient data to perform studies in the area of postmarketing surveillance studies. We determined the data requirements for postmarketing surveil-lance studies, implemented additional software in the electronic patient records of the general practitioner, developed an organization to monitor the use of data, and performed validation studies to test the quality of the data. Analysis of the data requirements showed that additional software had to be installed to collect data that is not recorded in routine practice. To avoid having to obtain informed consent from each enrolled patient, we developed IPCI as a semianonymous system: both patients and participating general practitioners are anonymous for the researchers. Under specific circumstances, the researcher can contact indirectly (through a trusted third party) the physician that made the data available. Only the treating general practitioner is able to decode the identity of his patients. A Board of Supervisors predominantly consisting of participating general practitioners monitors the use of data. Validation studies show the data can be used for postmarketing surveillance. With additional software to collect data not normally recorded in routine practice, data from electronic patient record of general practitioners can be used for postmarketing surveillance.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Marina Beckmann ◽  
Kerstin Dittmer ◽  
Julia Jaschke ◽  
Ute Karbach ◽  
Juliane Köberlein-Neu ◽  
...  

Abstract Background The need for and usage of electronic patient records within hospitals has steadily increased over the last decade for economic reasons as well as the proceeding digitalization. While there are numerous benefits from this system, the potential risks of using electronic patient records for hospitals, patients and healthcare professionals must also be discussed. There is a lack in research, particularly regarding effects on healthcare professionals and their daily work in health services. The study eCoCo aims to gain insight into changes in interprofessional collaboration and clinical workflows resulting from introducing electronic patient records. Methods eCoCo is a multi-center case study integrating mixed methods from qualitative and quantitative social research. The case studies include three hospitals that undergo the process of introducing electronic patient records. Data are collected before and after the introduction of electronic patient records using participant observation, interviews, focus groups, time measurement, patient and employee questionnaires and a questionnaire to measure the level of digitalization. Furthermore, documents (patient records) as well as structural and administrative data are gathered. To analyze the interprofessional collaboration qualitative network analyses, reconstructive-hermeneutic analyses and document analyses are conducted. The workflow analyses, patient and employee assessment analyses and classification within the clinical adoption meta-model are conducted to provide insights into clinical workflows. Discussion This study will be the first to investigate the effects of introducing electronic patient records on interprofessional collaboration and clinical workflows from the perspective of healthcare professionals. Thereby, it will consider patients’ safety, legal and ethical concerns and quality of care. The results will help to understand the organization and thereby improve the performance of health services working with electronic patient records. Trial registration The study was registered at the German clinical trials register (DRKS00023343, Pre-Results) on November 17, 2020.


2012 ◽  
Vol 30 (2) ◽  
pp. 227-232 ◽  
Author(s):  
F. Stevenson ◽  
N. Lloyd ◽  
L. Harrington ◽  
P. Wallace

2021 ◽  
Author(s):  
Hongfan Yu ◽  
Qingsong Yu ◽  
Yuxian Nie ◽  
Wei Xu ◽  
Yang Pu ◽  
...  

BACKGROUND High-frequent patient-reported outcome (PRO) assessments are used to measure patients’ symptoms after surgery for surgical research; however, quality of those longitudinal PRO data has seldom been discussed. OBJECTIVE To describe errors, to identify factors influencing the data quality, and to profile error trajectories of data longitudinally collected via paper-and-pencil (P&P) or web-based-assessment (ePRO) after thoracic surgery. METHODS We extracted longitudinal PRO data from two prospective clinical studies. PROs were assessed by the MD Anderson Symptom Inventory Lung Cancer Module and single-item Quality of Life Scale before surgery and then daily after surgery until discharge or up to 14 days of hospitalization. Patient compliance and data error were identified and compared between P&P and ePRO. Generalized estimating equations models and two-piecewise models were used to describe trajectories of error incidence over time and to identify the risk factors. RESULTS Among 629 patients with at least 2 PRO assessments, 440 completed 3347 P&P assessments and 189 completed 1291 ePRO assessments. In total, 49.44% of patients had at least 1 error, including 1) missing items (64.69%), 2) modifications without signatures (27.99%), 3) selection of multiple options (3.02%), 4) missing patient signatures (2.54%), 5) missing researcher signatures (1.45%) and 6) missing completion dates (0.3%). ePRO patients had fewer errors than P&P patients (30.16% vs. 57.73%, p <0.0001). Compared with ePRO patients, those using P&P were older, less educated and sicker. Common risk factors of having errors were with a lower education level (P&P, OR=1.39, 95%CL=1.20-1.62, p<.0001; ePRO, OR=1.82, 95%CI=1.22-2.72, p=0.0032), treated in a provincial hospital (P&P, OR=3.34, 95%CI=2.10-5.33, p<.0001; ePRO, OR=4.73, 95%CI=2.18-10.25, p<.0001) and with severe disease (P&P, OR=1.63, 95%CI=1.33-1.99, p<.0001; ePRO, OR=2.70, 95%CI=1.53-4.75, p=0.0006). Errors peaked on postoperative day (POD) 1 for P&P, and on POD 2 for ePRO. CONCLUSIONS ePRO might be superior to P&P in terms of data quality. However, sampling bias needs to be considered for studies using longitudinal PROs as major outcomes.


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